Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
University of Valencia
42 participants
May 21, 2024
INTERVENTIONAL
Conditions
Summary
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values \> 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.
Eligibility
Inclusion Criteria5
- BMI: 27-29.9 or 30-39.9
- Plasmatic glucose: < 100mg/dl or 100-125mg/dl
- Glycosylated hemoglobin: < 5.7 or 5.7-6.4
- LDL cholesterol > 115mg/dL
- Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.
Exclusion Criteria9
- Subjects on cholesterol-lowering pharmacological treatment
- Smokers
- Alcohol consumption above 30 g/day
- Pregnant or lactating women
- Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)
- Diseases of the gastrointestinal tract
- Antibiotic, hormonal or anabolic treatment
- Participants consuming foods enriched with PS or food supplements that contain PS
- Participants who follow specialist weight loss diets, vegans or vegetarians
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Interventions
PS-containing dietary supplement Sachet containing a powdered microencapsulated free plant sterols (2 g ingredient/day) during 8 weeks
Sachet containing the powdered excipients of the dietary supplement during 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06481020